Parkinson DiseaseNCT04569981
Sport Climbing With Parkinson's Disease
A study testing Climbing and Unsupervised activity group in people with Parkinson Disease, run by Medical University of Vienna at 1 site in Austria.
Trial summary
This controlled interventional study will investigate the effects of a 12-weeks sport climbing course compared to 24 weeks of unsupervised physical exercise on motor symptoms in Parkinson's disease Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Climbing and Unsupervised activity group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteAustria
- Study dates
- 5 Jun 2018to 29 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Idiopathic Parkinson's disease
- HY stage 1-3
Who cannot join
- cognitive impairment
- severe hearing or visual impairment
- severe orthopedic problems
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna, Department of Neurology
Vienna, 1090
About this study
Official title: Climb up, Heads up: Sport Climbing With Parkinson's Disease
This controlled interventional study will investigate the effects of a 12-weeks sport climbing course compared to 24 weeks of unsupervised physical exercise on motor symptoms in Parkinson's disease
Read the detailed description
The primary aim of this study is to evaluate the effects of a 12-week sport climbing course versus unsupervised physical exercise on motor symptoms in patients with Parkinson's disease.
Background: Sport climbing (SC) is known as a whole-body workout, which additionally trains cognitive, mental, and social abilities. In contrast to its public image, SC in a controlled environment using "top-rope" belay, is a safe sport and can be performed at any age and at any level. In the field of neurological rehabilitation, it is already used as "therapeutic SC" for other neurological diseases, such as stroke, multiple sclerosis, depressions etc. but studies on climbing in PD patients are lacking.
Hypothesis: to find significant improvement of motor symptoms in the climbing group compared to the control group as well as biopsychosocial improvements after 6 weeks, 12 weeks, and 6 months after the intervention.
Methods: Effects of SC on motor symptoms in 48 PD patients in total, who will be randomized into a climbing group (n=24) and a control group (n=24) will be evaluated. The climbing group will follow a 12-week 90 min/week climbing trainings course, led by professional climbing instructors.
The control group will receive education/information material of the European physiotherapy guidelines for physical activity recommended by the WHO and will be instructed to follow the recommendation of the guidelines to independently live an active lifestyle and train unsupervised. All patients will be evaluated with clinical assessments at baseline, in between the study period (mid), after completing the 12-weeks study period (post). As additional outcomes, health benefits of SC in PD with a holistic approach, covering biopsychosocial aspects will be investigated. Therefore, non-motoric and motoric parameters will be evaluated, and follow-up assessments 6 months after.
- Conditions
- Parkinson Disease
- Being tested
- Climbing, Unsupervised activity group
- Keywords
- Parkinson's disease, sport climbing, motor symptoms, training therapy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClimbingOther
The patients in the Climbing Group (CG) followed a 12-weeks long climbing trainings course in small groups of 3-4 participants with a certified climbing instructor.
Unsupervised activity groupOther
The patients in the unsupervised activity group (UAG) received education European physiotherapy guidelines for physical activity recommended by the WHO of recommended activity and followed their self-selected activities over 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Climbing Group (CG) | Active comparator | The patients in the Climbing Group (CG) followed a 12-weeks long climbing trainings course in small groups of 3-4 participants with a certified climbing instructor. Receives: Other: Climbing |
| Unsupervised active group (UAG) | Active comparator | The patients in the unsupervised activity group (UAG) received education European physiotherapy guidelines for physical activity recommended by the WHO of recommended activity and followed their self-selected activities over 12 weeks. Receives: Other: Unsupervised activity group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Rating
Motor Part of the Movement Disorders Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) III
Measured: Testpoints: Change from Baseline Score after 12 weeks of the intervention
Secondary outcomes (7)
Change in Gait and Balance using wearable sensors
Inertial Sensors will be used to quantify gait metrics (postural sway, gait cycle, speed) as participants conduct walking and balance trials
Measured: Testpoints: Change after 12 weeks of the intervention
Quantified Bradykinesia test
Changes in a quantified bradykinesia Tests by using a standardized speeded keyboard tapping task. Changes will be evaluates in keys/second
Measured: Testpoints: Change after 12 weeks of the intervention
Hand grip strength
Assessment of hand grip strength, using a dynamometer. Results will be evaluated in Kilogramms
Measured: Testpoints: Change after 12 weeks of the intervention
Parkinson Quality of Life Questionaire-39 (PDQ-39)
Quality of life, assessed by the PDQ-39 Questionnaire
Measured: Testpoints: Change after 12 weeks of the intervention
Social Outcomes
Questionnaiers about social effects
Measured: Testpoints: Change after 12 weeks of the intervention
Cognitive assessments
Change in cognition will be assessed using a standardized cognitive assessment battery, measuring following domains: executive functions, memory, attention and verbal functions
Measured: Testpoints: Change after 12 weeks of the intervention
Changes in brain functional and structural MRI (resting state paradigma) and Changes in brain structural and functional MRI
Changes in structural and functional MRI (resting state paradigma) will be assessed
Measured: Testpoints: Change after 12 weeks of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start5 Jun 2018
- Primary completion29 Jul 2019
- Study completion29 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants were randomly assigned to either the climbng group or the unsupervised active group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- University of Vienna, University Hospital Schleswig-Holstein
- Responsible party
- Principal investigator, Heidemarie Zach, MD, BSc., Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569981
- Sponsor's protocol ID
- 1369/2017
- Status last verified
- Sep 2020
- First submitted
- 17 Aug 2020
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Langer A, Hansen C, Roth D, Santer A, Flotz A, Gruber J, Wizany L, Hasenauer S, Pokan R, Dabnichki P, Treven M, Zimmel S, Schmoeger M, Willinger U, Gassner L, Brucke C, Maetzler W, Zach H. Vertical locomotion improves horizontal locomotion: effects of climbing on gait and other mobility aspects in Parkinson's disease. A secondary analysis from a randomized controlled trial. J Neuroeng Rehabil. 2024 Apr 27;21(1):63. doi: 10.1186/s12984-024-01363-4.
PubMed 38678241
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Climb up, Heads up: Sport Climbing With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04569981
- Acronym / sponsor ID
- 1369/2017
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's disease, sport climbing, motor symptoms, training therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- University of Vienna, University Hospital Schleswig-Holstein
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 29 Jul 2019 (actual)
- Study completion
- 29 Jul 2019 (actual)
- First posted
- 30 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This controlled interventional study will investigate the effects of a 12-weeks sport climbing course compared to 24 weeks of unsupervised physical exercise on motor symptoms in Parkinson's disease
Detailed description
The primary aim of this study is to evaluate the effects of a 12-week sport climbing course versus unsupervised physical exercise on motor symptoms in patients with Parkinson's disease.
Background: Sport climbing (SC) is known as a whole-body workout, which additionally trains cognitive, mental, and social abilities. In contrast to its public image, SC in a controlled environment using "top-rope" belay, is a safe sport and can be performed at any age and at any level. In the field of neurological rehabilitation, it is already used as "therapeutic SC" for other neurological diseases, such as stroke, multiple sclerosis, depressions etc. but studies on climbing in PD patients are lacking.
Hypothesis: to find significant improvement of motor symptoms in the climbing group compared to the control group as well as biopsychosocial improvements after 6 weeks, 12 weeks, and 6 months after the intervention.
Methods: Effects of SC on motor symptoms in 48 PD patients in total, who will be randomized into a climbing group (n=24) and a control group (n=24) will be evaluated. The climbing group will follow a 12-week 90 min/week climbing trainings course, led by professional climbing instructors.
The control group will receive education/information material of the European physiotherapy guidelines for physical activity recommended by the WHO and will be instructed to follow the recommendation of the guidelines to independently live an active lifestyle and train unsupervised. All patients will be evaluated with clinical assessments at baseline, in between the study period (mid), after completing the 12-weeks study period (post). As additional outcomes, health benefits of SC in PD with a holistic approach, covering biopsychosocial aspects will be investigated. Therefore, non-motoric and motoric parameters will be evaluated, and follow-up assessments 6 months after.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- The participants were randomly assigned to either the climbng group or the unsupervised active group
| Arm | Type | Receives |
|---|---|---|
| Climbing Group (CG) | Active comparator | Other: ClimbingThe patients in the Climbing Group (CG) followed a 12-weeks long climbing trainings course in small groups of 3-4 participants with a certified climbing instructor. |
| Unsupervised active group (UAG) | Active comparator | Other: Unsupervised activity groupThe patients in the unsupervised activity group (UAG) received education European physiotherapy guidelines for physical activity recommended by the WHO of recommended activity and followed their self-selected activities over 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Idiopathic Parkinson's disease
- HY stage 1-3
Key exclusion criteria (3 listed)
- cognitive impairment
- severe hearing or visual impairment
- severe orthopedic problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClimbingThe patients in the Climbing Group (CG) followed a 12-weeks long climbing trainings course in small groups of 3-4 participants with a certified climbing instructor. | Other | Climbing Group (CG) |
| Unsupervised activity groupThe patients in the unsupervised activity group (UAG) received education European physiotherapy guidelines for physical activity recommended by the WHO of recommended activity and followed their self-selected activities over 12 weeks. | Other | Unsupervised active group (UAG) |
Primary outcome
Clinical Rating
Time frame: Testpoints: Change from Baseline Score after 12 weeks of the intervention
Motor Part of the Movement Disorders Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) III
7 secondary outcomes
Change in Gait and Balance using wearable sensors
Time frame: Testpoints: Change after 12 weeks of the intervention
Quantified Bradykinesia test
Time frame: Testpoints: Change after 12 weeks of the intervention
Hand grip strength
Time frame: Testpoints: Change after 12 weeks of the intervention
Parkinson Quality of Life Questionaire-39 (PDQ-39)
Time frame: Testpoints: Change after 12 weeks of the intervention
Social Outcomes
Time frame: Testpoints: Change after 12 weeks of the intervention
Cognitive assessments
Time frame: Testpoints: Change after 12 weeks of the intervention
Changes in brain functional and structural MRI (resting state paradigma) and Changes in brain structural and functional MRI
Time frame: Testpoints: Change after 12 weeks of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Derived from this study: PubMed 38678241Langer A, Hansen C, Roth D, Santer A, Flotz A, Gruber J, Wizany L, Hasenauer S, Pokan R, Dabnichki P, Treven M, Zimmel S, Schmoeger M, Willinger U, Gassner L, Brucke C, Maetzler W, Zach H. Vertical locomotion improves horizontal locomotion: effects of climbing on gait and other mobility aspects in Parkinson's disease. A secondary analysis from a randomized controlled trial. J Neuroeng Rehabil. 2024 Apr 27;21(1):63. doi: 10.1186/s12984-024-01363-4.
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Climbing and Unsupervised activity group in people with Parkinson Disease, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Rating (time frame: Testpoints: Change from Baseline Score after 12 weeks of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04569981, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2020.